Hydrochlorothiazide
- Product NDC
- 0228-2820
- 11-digit product format
- 002282820
- Labeler code
- 0228
- Product ID
- 0228-2820_2b5bc2c3-8d3c-43c8-8e4c-e44aca5624cd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA040707
- Marketing category
- ANDA
- Marketing start
- 2007-03-12
- Marketing end
- 2027-06-30
- Substance
- HYDROCHLOROTHIAZIDE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrochlorothiazide
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH |
| Rxcui | 429503 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0228-2820-11 | Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 0228-2820-96 | Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] | 4 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] | 4 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] | 4 | |
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] | 2 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] | 2 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] | 2 | |
| Hydrochlorothiazide | ACTIVE INGREDIENT | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Hydrochlorothiazide | ACTIVE MOIETY | 0J48LPH2TH | HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| calcium stearate | INACTIVE INGREDIENT | 776XM7047L | HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium lauryl sulfate | INACTIVE INGREDIENT | 368GB5141J | HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0228-2820 | HYDROCHLOROTHIAZIDE TABLET [ACTAVIS PHARMA, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20231202_afdf1170-25a0-496d-b293-36ee0db2cd1e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0228-2820-11 | 00228282011 | 100 TABLET in 1 BOTTLE (0228-2820-11) | 100 tablet | 2007-03-12 | 2027-06-30 | No | No | Current |
| 0228-2820-96 | 00228282096 | 1000 TABLET in 1 BOTTLE (0228-2820-96) | 1000 tablet | 2023-12-01 | 2027-06-30 | No | No | Historical |